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Safety and Efficacy of Cariprazine for Mania

NCT ID: NCT01058096

Last Updated: 2017-04-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

323 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-07-31

Brief Summary

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The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.

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Detailed Description

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Conditions

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Bipolar Disorder Mania

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cariprazine

Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.

Group Type EXPERIMENTAL

Cariprazine

Intervention Type DRUG

Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine.

Placebo

Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients who meet eligibility criteria will be administered a once daily oral dose of placebo.

Interventions

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Cariprazine

Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine.

Intervention Type DRUG

Placebo

Patients who meet eligibility criteria will be administered a once daily oral dose of placebo.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who have provided informed consent prior to any study specific procedures
* Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without psychotic symptoms
* Voluntarily hospitalized for current manic episode
* Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria

* Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gedeon Richter Ltd.

INDUSTRY

Sponsor Role collaborator

Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Diaz, MD

Role: STUDY_DIRECTOR

Forest Laboratories

Locations

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Forest Investigative Site 004

Long Beach, California, United States

Site Status

Forest Investigative Site 005

Riverside, California, United States

Site Status

Forest Investigative Site 007

San Diego, California, United States

Site Status

Forest Investigative Site 009

Chicago, Illinois, United States

Site Status

Forest Investigative Site 006

Lake Charles, Louisiana, United States

Site Status

Forest Investigative Site 001

Flowood, Mississippi, United States

Site Status

Forest Investigative Site 003

Creve Couer, Missouri, United States

Site Status

Forest Investigative Site 008

Cleveland, Ohio, United States

Site Status

Forest Investigative Site 010

Oklahoma City, Oklahoma, United States

Site Status

Forest Investigative Site 002

Houston, Texas, United States

Site Status

Forest Investigative Site 106

Vijayawada, Andhra Pradesh, India

Site Status

Forest Investigative Site 112

Vizag, Andhra Pradesh, India

Site Status

Forest Investigator Site 108

Varanasi, Durgakund, India

Site Status

Forest Investigative Site 103

Ahmedabad, Gujarat, India

Site Status

Forest Investigative Site 120

Ahmedabad, Gujarat, India

Site Status

Forest Investigative Site 105

Bangalore, Karnataka, India

Site Status

Forest Investigative Site 107

Bangalore, Karnataka, India

Site Status

Forest Investigative Site 118

Mangalore, Karnataka, India

Site Status

Forest Investigative Site 113

Mangalore, Karnataka, India

Site Status

Forest Investigative Site 115

Manipal, Karnataka, India

Site Status

Forest Investigative Site 114

Mysore, Karnataka, India

Site Status

Forest Investigative Site 101

Aurangabad, Maharashtra, India

Site Status

Forest Investigative Site 110

Nashik, Maharashtra, India

Site Status

Forest Investigative Site 111

Pune, Maharashtra, India

Site Status

Forest Investigative Site 104

Pune, Maharashtra, India

Site Status

Forest Investigative Site 121

Chennai, Tamil Nadu, India

Site Status

Forest Investigative Site 109

Kanpur, Uttar Pradesh, India

Site Status

Forest Investigative Site 119

Lucknow, Uttar Pradesh, India

Site Status

Countries

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United States India

References

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McIntyre RS, Masand PS, Earley W, Patel M. Cariprazine for the treatment of bipolar mania with mixed features: A post hoc pooled analysis of 3 trials. J Affect Disord. 2019 Oct 1;257:600-606. doi: 10.1016/j.jad.2019.07.020. Epub 2019 Jul 5.

Reference Type DERIVED
PMID: 31344528 (View on PubMed)

Earley W, Durgam S, Lu K, Ruth A, Nemeth G, Laszlovszky I, Yatham LN. Clinically relevant response and remission outcomes in cariprazine-treated patients with bipolar I disorder. J Affect Disord. 2018 Jan 15;226:239-244. doi: 10.1016/j.jad.2017.09.040. Epub 2017 Sep 25.

Reference Type DERIVED
PMID: 29017067 (View on PubMed)

Other Identifiers

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RGH-MD-32

Identifier Type: -

Identifier Source: org_study_id

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